A Trial to Investigate the Pharmacokinetics (PK) of Single Doses of 200 µg, 400 µg and 2 x 400 µg of Intranasal Fentanyl Spray (INFS) in Healthy Subjects

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall clinical trial objective is to gain information about the Pharmacokinetics (PK) of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male and female subjects are planned to be randomized in the trial. Subjects will be randomized to one of two treatment sequences and treated with 3 different dosages (either 200 µg/dose INFS, 400 µg/dose or 400 µg two doses administered 10 minutes apart) over two days. Subjects will be hospitalized over a period of total 5 days, where safety assessments and pharmacokinetic samplings will be conducted.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Fentanyl

Criteria

Eligibility Criteria:

Healthy male and female Caucasian or Black subjects between 18 and 55 years with a body mass index of 18-28 kg/m2 and a minimum weight of 50 kg.